By Peter McCullough, M.D. and John Leake
The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) warned America and the world the mRNA COVID-19 vaccines could result in heart inflammation, or myocarditis, in 2021.
Past incidences of this medical problem unrelated to vaccines occurred at a low rate of approximately 4 per million population per year, as reported by Arola et al., from Finland. In general, approximately 90 percent of cases occur in men and approximately 10 percent in women.
Managing myocarditis includes stopping all forms of exercise, which can be a driver of the development of heart failure and a trigger for sudden death. In cases where there is a progression to heart failure, cardiac biopsy is commonly performed to establish or rule out a diagnosis of giant cell myocarditis, which has a markedly worse prognosis than the other forms, such as the inflammation caused by parvovirus and other diseases.
Vaccine Connection
COVID-19 vaccination has been thrust on the world with such vehemence, physicians and hospitals have been hesitant to voluntarily report cases to regulatory agencies.
The vast majority of physicians took COVID-19 vaccines themselves and may be having trouble coming to personal grips with the threat of heart damage and other risks of vaccination.
In 2021, as spontaneous reports came into agencies that predominately young men were developing myocarditis with COVID-19 vaccination, a pattern emerged. First, the highest risk group was males aged 18 to 24 years, with a skewed distribution and a long tail extending to men in their seventies. Second, approximately 90 percent of cases required hospitalization. Third, the risk exploded after the second injection, and deaths directly due to myocarditis were confirmed by autopsy.
In biological licensing agreement letters to Pfizer and Moderna, the FDA requested prospective cohort studies of myocarditis, including blood tests, electrocardiography (ECG), and cardiac imaging before injections and periodically afterward. The studies would aim to detect the real rate of heart damage and to ascertain how much of the problem could be asymptomatic and potentially present a future risk of sudden death in an unsuspecting patient.
Both companies were not forthcoming, so the answer came from Mansanguan et al, from the Bhumibol Adulyadej Hospital in Bangkok, Thailand. Adolescents aged 13-18 were studied in a prospective cohort manner just after the second injection of the Pfizer vaccine and seven out of 301 (23,256 per million) developed myocarditis using a clinical definition based on blood tests, ECG, and cardiac imaging.
Data from multiple sources suggest the condition can be subclinical in about half of cases, meaning neither the patient nor the parents bring it to clinical attention. Patone et al., have recently reported on 100 fatal cases of vaccine-induced myocarditis in the United Kingdom, and such papers are expected to continue with larger numbers as the medical community begins to fully recognize cause and effect.
Tip of the Iceberg
The spontaneous reports of myocarditis to public health agencies represent the tip of a very large iceberg.
If the estimated incidence of vaccine-linked myocarditis in the Mansanguan study is confirmed, or anywhere close to approximately 25,000 per million, a million young Americans could have sustained heart damage from COVID-19 vaccination and some of them will be at risk for cardiac arrest and future heart failure.
These data suggest we should not be surprised by rising rates of sudden death in young persons playing sports and during daily life, including sleep. There can be no more urgent need to halt vaccination and commit a substantial research effort into screening, detection, prognosis, and management of COVID-19 vaccine-induced myocarditis. The stakes are high: an entire generation is at risk.
Peter McCullough, M.D., M.P.H. (petermcculloughmd@substack.com) is an internist, cardiologist, epidemiologist, and the Chief Scientific Officer of The Wellness Company.
John Leake, is the co-author, along with Dr. McCullough, of the book, “The Courage to Face COVID-19”. A version of this article appeared in the Substack, Courageous Discourse, on October 18, 2022. Reprinted with permission.
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